February 2024 IRB Review Newsletter

February 2024

The IRB Review

A compilation of information, announcements, & updates for UK Institutional Review Board (IRB) members, research investigators, & others involved with human subject research.

Video Link

HIPAA at UK

Health Insurance Portability and Accountability Act (HIPAA) is a complex regulation that affects many researchers at the University of Kentucky. HIPAA was designed to protect the use and disclosure of Protected Health Information (PHI). A new training video is available to help researchers comply with HIPAA law.

Text Link

A new training course is available for non-UK teachers and support staff acting as study personnel for research in a K-12 classroom. The course does satisfy the requirements for Human Subject Protection (HSP) training for non-UK teachers and support staff study personnel. The course does not qualify as HSP training for UK employees or students.

The Principle Investigator (PI) conducting research in a K-12 classroom is responsible for providing the course information to their non-UK study personnel. The PI should also notify ORI upon the course completion. The course completion certificate along with study personnel's name can be emailed to HSPTrainingSupport@uky.edu.

Launch Course

In 1972, the Washington Star published an article on the U.S. Public Health Service Syphilis Study that began in 1932. Public outcry occurred in response to front-page news that the U.S. Government conducted unethical research on over 400 black men in Tuskegee, Alabama. The men were told they were being treated for “bad blood.” They were really being used as research subjects to determine the long-term effects of untreated syphilis.

In February 1994 in Human Research History, a symposium on the syphilis study entitled "Doing Bad in the Name of Good" was held in Charlottesville, VA. The Tuskegee Syphilis Legacy Committee emerged because of the symposium. One of the main objectives of the Legacy Committee was to obtain an apology on behalf of the U.S. Government. As a result, President Bill Clinton issued a formal apology to the surviving participants in 1997.

The men who participated in the U.S Public Health Service Syphilis Study remained untreated even after the use of penicillin to treat syphilis became common practice in the 1940s. Are there informed consent elements in the Common Rule 45 CFR 46 that speak directly to this type of failure to inform?

Yes or No?

***Keep Reading for the Answer***

Upcoming ORI Office Hours

Thursday, February 29, 12:30 - 1:30 pm

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Click Here for All Office Hours Dates/Times

The Office of Research Integrity offers consultations by phone, Zoom, or in-person. Consultations are offered for studies in development (with or without an E-IRB submission) as well as approved research projects.

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Answer to the Trivia Question: Yes

General Requirements for Informed Consent 46.116 (b)(4) states informed consent must include, “A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.” A disclosure like this would require researchers to inform participants enrolled in the syphilis study after penicillin became a common practice in the 1940s that an “alternative” course of treatment was available.

Additional Elements of Informed Consent 46.116 (c)(5) upholds, “A statement that significant new findings developed during the course of the research that may relate to the subject’s willingness to continue to participate will be provided to the subjects.” A statement such as this would require researchers to inform participants of the significance of treating syphilis with penicillin once it became common practice.